MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRU-CORE II URO BIOPSY INSTRUMENT 18GA X 20CM

Model Number	763418200X
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
The reporter indicated "high number of revisions for rectal bleeding following the use of these biopsy needles prostate (5 in 1 month, 3 different operators).For the urology team, the bevel is reversed on these needles.This can cause injury and bleeding.".
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.There were zero other complaints found related to the log number.The customer did not return any samples for evaluation.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.Determining a root cause and corrective action is not possible.No corrective action is required at this point.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.

• Brand Name: TRU-CORE II URO BIOPSY INSTRUMENT 18GA X 20CM
• Common Device Name: TRU-CORE II
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19662680
• Report Number: 0001625425-2024-01057
• Device Sequence Number: 6737349
• Product Code: KNW
• UDI-Device Identifier: 00886333006809
• UDI-Public: (01)00886333006809(07)280706(10)11486505
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 763418200X
• Device Lot Number: 11486505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown